NCT07120841

Brief Summary

This study aims to evaluate the effect of follow-up telephone education provided by a nurse on the levels of anxiety, stress, and depression in patients hospitalized in the cardiac intensive care unit during the two weeks after discharge. Patients will be randomly assigned to either the intervention (education) group or the control group. Their levels of anxiety, stress, and depression will be measured before and after the intervention. The aim is to determine whether this educational intervention can improve the psychological well-being of these patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 23, 2023

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2023

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 6, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 13, 2025

Completed
Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

28 days

First QC Date

August 6, 2025

Last Update Submit

August 6, 2025

Conditions

Keywords

Cardiovascular patientsDepression, Anxiety, StressTelephone follow-up nursing

Outcome Measures

Primary Outcomes (1)

  • Depression, Anxiety, stress Score(DASS-21)

    Changes in depression, anxiety, stress scores as measured by DASS-21

    2 weeks after discharge

Study Arms (2)

Intervention Group

EXPERIMENTAL

Patients receive telephone follow-up education by nurse.

Behavioral: Telephone Education

Control Group

ACTIVE COMPARATOR

Patients receive usual care without follow-up education.

Behavioral: Standard Care (in control arm)

Interventions

Participants in this group will receive telephone follow-up education by a nurse during the two weeks after discharge

Intervention Group

Participants in this group will receive standard post-discharge care without any follow-up telephone education

Control Group

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsNo restriction based on gender identity.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent obtained from both the patient and their family.
  • Definite diagnosis of heart disease confirmed by a specialist physician.
  • No previous history of psychological problems, based on the patient's medical records.
  • No prior participation in similar educational programs.

You may not qualify if:

  • Non response to the nurse's follow-up calls.
  • Failure to complete the survey.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khatam Hospital, Behshahr

Sari, Mazandaran, 4817749365, Iran

Location

MeSH Terms

Conditions

DepressionAnxiety DisordersCardiovascular Diseases

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will be randomized in a parallel assignment to intervention and control groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of health education and promotion

Study Record Dates

First Submitted

August 6, 2025

First Posted

August 13, 2025

Study Start

November 23, 2023

Primary Completion

December 21, 2023

Study Completion

December 21, 2023

Last Updated

August 13, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared for this study

Locations